NCT07842094

Brief Summary

This study is an assessor-blinded randomised controlled trial investigating the effects of combined Lifestyle-integrated Functional Exercise and Self-initiated Perturbation-based Balance Training (LiFE-SePBT) on postural stability in community-dwelling older adults with an elevated risk of falling.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
39mo left

Started Jun 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress9%
Jun 2026Dec 2029

Study Start

First participant enrolled

June 12, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2026

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2029

Last Updated

October 1, 2026

Status Verified

September 1, 2026

Enrollment Period

2.5 years

First QC Date

September 21, 2026

Last Update Submit

September 28, 2026

Conditions

Keywords

Lifestyle-integrated Functional ExerciseReactive balanceDynamic balanceFall preventionSelf-initiated Perturbation-based Balance Training

Outcome Measures

Primary Outcomes (1)

  • Generic Balance ability

    Generic balance ability will be assessed by the Mini-BESTest. Mini-BESTest can challenge balance across anticipatory postural adjustments, postural responses, sensory orientation and stability in gait, allowing for a comprehensive examination of improvements that occur in reactive control.

    Week 0 (baseline assessment), week 10 (post-assessment), week 22 (i.e., 3-month follow-up assessment)

Secondary Outcomes (12)

  • Number of real-life falls

    1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months, 11 months, and 12 months after the intervention.

  • Dynamic balance

    Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.

  • Balance confidence

    Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.

  • Functional lower body strength

    Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.

  • Number of laboratory falls

    Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.

  • +7 more secondary outcomes

Study Arms (2)

LiFE-SePBT

EXPERIMENTAL

5 sessions of combined Lifestyle-integrated Functional Exercise and Self-initiated Perturbation-based Balance Training (LiFE-SePBT) will be delivered. The LiFE component involves having participants embed functional exercises into their lifestyle, as well as practising recovering their balance upon self-initiated perturbation. Each session is 90 minutes long and will be hosted once every 2 weeks.

Behavioral: Lifestyle-integrated Functional Exercise

Attention control group

PLACEBO COMPARATOR

Participants in the attention control group will receive 5 sessions of upper limb mobilisation and flexibility exercises. Each session is 90 minutes long and will be held once every 2 weeks.

Behavioral: Upper limb mobilisation and flexibility training

Interventions

Lifestyle-integrated Functional Exercise and Self-initiated Perturbation-based Balance Exercise (LiFE-SePBT) is a synergistic fall prevention programme. LiFE programme targets generic balance and muscle strength whereas SePBT mainly influences through reactive balance.

LiFE-SePBT

Upper limb mobilisation and flexibility training, including arm circles, deltoid stretches, shoulder internal rotations, etc.

Attention control group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Community-dwelling older adults aged 60 or older
  • Able to communicate effectively in Cantonese or Mandarin
  • Able to walk independently on level ground for at least 30 minutes
  • A score of ≥ 6 in the Abbreviated Mental Test (Hong Kong)
  • Have fallen in the preceding year, have concerns about falling, or feel unsteady while walking or standing

You may not qualify if:

  • Uncorrected vision or hearing impairment
  • Osteoporosis
  • Hip or knee replacement within the last year
  • Resting blood pressure ≥ 160/100 mmHg even with medication taken
  • A score of ≤ 6 in 5-items Geriatric Depression Scale (GDS-5)
  • Have musculoskeletal, cardiovascular, mental, or neurological disorders that preclude their participation in the assessment or intervention safety

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hong Kong Polytechnic University

Hung Hom, Kowloon, 000, Hong Kong

RECRUITING

Study Officials

  • Charlotte Sau Lan Tsang, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bryan Tsz Lok Heung, Bsc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 21, 2026

First Posted

September 25, 2026

Study Start

June 12, 2026

Primary Completion (Estimated)

December 17, 2028

Study Completion (Estimated)

December 17, 2029

Last Updated

October 1, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Due to participant privacy concerns.

Locations